Biologic Treatments Safe to Recommend for IgE-Mediated Food Allergy, Study Suggests

Ulugbek Nurmatov, MD, PhD | Image Credit: Liverpool School of Tropical Medicine

According to a recent systematic review and meta-analysis examining the safety and efficacy of omalizumab (OMA) and similar biologics in treating IgE-mediated food allergy (FA), patient-specific factors are a critical concern when attempting to reduce food-induced allergic reaction risk.¹

Although oral immunotherapy (OIT) has long been effective in desensitizing patients to specified allergens, several limitations, such as a lack of standardization and adverse effects, limit its use. Biologics, however, are more broadly applicable, as they target underlying immunologic pathways driving allergic reactions. OMA is the most studied biologic in this space; it has been approved for both adjunct therapy with oral immunotherapy and as a monotherapy.²

“The use of biologics, either as monotherapy or in combination with OIT, offers a cutting-edge approach to FA management,” wrote Ulugbek Nurmatov, MD, PhD, division of population medicine, School of Medicine, Cardiff University, and colleagues. “However, despite the growing body of research, the optimal use of biologics in FA treatment, including timing, duration, combination strategies, and cost-effectiveness remains to be fully elucidated.”¹

Investigators collected data from medical databases including Cochrane Library, EMBASE, and ISI Web of Science, for randomized controlled trials (RCTs) examining biologics as monotherapy or in conjunction with OIT. Inclusion criteria were as follows:

• A population comprised of children (≤18 years) and adults (>18 years) with IgE-mediated FA confirmed by oral food challenge
• Biological therapy intervention (monotherapy or combined with OIT)
• A placebo comparator, no intervention, or routine management without active treatment

The primary outcomes included desensitization, sustained unresponsiveness or persistent desensitization, and biologics-related adverse reactions, including severe adverse events. Secondary outcomes included immunological outcomes such as skin prick testing (SPT), serum specific IgE and IgG4 concentrations, and total IgE levels, as well as quality of life (QoL) measures.¹

The team collected an initial total of 7791 relevant papers; 7719 were then excluded as either duplicates or irrelevant. An additional 9 uncontrolled studies, 8 observational studies, and 42 abstract papers were excluded. A final total of 13 RCTs and 2 US National Clinical Trials (NCTs) were included in the systematic review. Of these, 9 were assessed as having low risk of bias, 3 as moderate, and 1 as high risk.¹

A total of 1010 patients were included across the studies, with ages ranging from 1-60 years. Among these, 7 studies included both adults and children, 5 focused exclusively on adolescents, and 1 enrolled only adult patients.¹

All 13 included RCTs reported desensitization as an outcome; meta-analysis was conducted on pooled data from 10, as the remaining 3 were omitted due to heterogeneity. This analysis indicated an increased likelihood of tolerating 2g of protein from 2 foods, namely peanut and cow’s milk, with OMA as monotherapy or OMA with OIT compared to control (risk ratio [RR], 2.035; 95% CI, 1.29 to 3.22; 299 participants, 7 studies, I² = 50%, GRADE = moderate). Sensitivity analysis supported this finding (RR, 2.41; 95% CI, 1.38 to 4.2; 232 participants, 6 studies, I² = 29%).¹

Additionally, OMA increased food tolerance thresholds compared to placebo (RR, 4.9; 95% CI, 2.14 to 11.20; 235 participants, 3 studies, I² = 0%, GRADE = moderate). Regarding adverse effects, OMA reduced the risk of allergic reactions (RR, .55; 95% CI, .36 to .85) without increasing skin (RR, 1.09; 95% CI, .45 to 2.65) or other adverse or severe reactions. Investigators also noted a decrease in hypersensitivity and a lowered allergic and inflammatory response.¹

Despite noting this study as the most robust investigation to date within this sphere, investigators did note the key limitations of heterogeneous populations, interventions, outcomes, diversity of biologics, OIT protocols, and treatment modalities.¹

“More studies with long-term outcomes are needed to establish the effectiveness, tolerability and safety of biologics as a monotherapy or in combination with OIT,” Nurmatov and colleagues wrote. “In addition, standardized definitions and reporting of AEs and Ars secondary to treatment will allow for more comprehensive analysis and comparisons. Research on cost-effectiveness and quality of life impacts is also necessary to guide patient-centred care.”¹

References

1. Nurmatov UB, Lo Scalzo L, Galletta F, et al. Biologics in IGE-mediated food allergy: A systematic review and meta-analysis of Interventional Studies. World Allergy Organization Journal. 2025;18(7):101069. doi:10.1016/j.waojou.2025.101069

2. Sindher SB, Fiocchi A, Zuberbier T, Arasi S, Wood RA, Chinthrajah RS. The role of biologics in the treatment of food allergy. The Journal of Allergy and Clinical Immunology: In Practice. 2023;12(3):562-568. doi:10.1016/j.jaip.2023.11.032